Job Description

Conduct site qualification, initiation, monitoring (remote/interim), and closeout visits for pediatric and adult nutrition Phase 1-4 studies in compliance with protocols,

GCP, ICH

, and company SOPs. Set up and manage study sites in

Veeva Vault CTMS

; prepare, collect, update, and maintain essential study documents. Support vendor qualification and onboarding, and maintain good relationships with new and existing study-specific vendors. Conduct all clinical site activities per the monitoring plan, study timelines, and company objectives. Oversee and support clinical investigative sites across multiple protocols, motivating site staff to meet study objectives and recruitment goals. Ensure data quality and timely data submission, including proper reporting and follow-up of all safety events. Ensure the safety and protection of study participants in accordance with the monitoring plan, company SOPs, ICH guidelines, and applicable country regulations. Manage essential documents and EDPs, including collection, review, uploading, and sign-off in Veeva. Perform product accountability: verify on-site product inventory and identify discrepancies. Coordinate study product movement between depot and sites to ensure accurate tracking and adequate supply. Manage study materials, equipment, and device supplies to support smooth study execution. Prepare and submit IRB/IEC applications to obtain ethical approval. Train site personnel on the study protocol and regulatory requirements, in collaboration with project team members. Escalate major or unresolved site issues to the Clinical Project Manager as needed. Support Quality Assurance audits and ensure inspection readiness at assigned sites. Document monitoring activities accurately and submit clear, timely monitoring and administrative reports. Build effective, collaborative relationships with investigators, coordinators, and internal teams through regular communication.

Requirements

Bachelor's degree, preferably in a Clinical Science, Nutrition, Nursing, or in Healthcare/ Life Science At least

1-2 years

of experience in clinical research monitoring. Experience with

site/project management

and

on-site monitoring

of investigational products such as drugs, medical foods, or baby formulas. Solid understanding of

ICH/GCP

requirements and relevant local regulatory guidelines Experience in a compliance-driven environment is an advantage. Ability to work independently with minimal supervision.

Willingness

and

ability to travel

for planned and ad hoc

site visits monthly

. Strong English skills (reading, writing, speaking, and comprehension). Effective communication, problem-solving, organization, and time-management skills.
For those who have what it takes, please apply online or send in your profile to:

Consultant: Wei Li

Tel: 03-7954 8440

For more job opportunities, please visit:

www.brightprospect.com.my/Job_Listing.php

OUR SERVICE FOR JOB SEEKER IS FREE!

Job Type: Full-time

Pay: RM6,000.00 - RM8,000.00 per month

Benefits:

Health insurance
Work Location: In person